Last updated: 11/07/2018 07:04:19
Evaluation of antibody persistence and immune memory against the hepatitis B antigen in previously vaccinated children
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Antibody persistence and immune memory against the hepatitis B antigen in 11-12 year old children, previously vaccinated with DTPa-HBV-IPV/Hib vaccine in study 217744/031
Trial description: This study will evaluate the persistence of immunity to hepatitis B 10 to 11 years after vaccination with Infanrix hexa™ or Engerix™-B and also the ability to mount an immune response to the challenge dose of Engerix™-B.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of subjects with anti-hepatitis B (anti-HBs) antibody concentration equal to or above (≥) 100 milli-International units per milliliter (mIU/mL)
Timeframe: One month after a challenge dose of Engerix-B vaccine
Secondary outcomes:
Number of subjects with an anamnestic response to a challenge dose
Timeframe: Before and one month after a challenge dose of Engerix-B vaccine
Number of subjects with anti-HBs antibody concentration ≥ 6.2 mIU/mL
Timeframe: Before and one month after a challenge dose of Engerix-B vaccine
Number of subjects with anti-HBs antibody concentration ≥ 10 mIU/mL
Timeframe: Before and one month after a challenge dose of Engerix-B vaccine
Number of subjects with anti-HBs antibody concentration ≥ 100 mIU/mL
Timeframe: Before the challenge dose of Engerix-B vaccine
Number of subjects reporting solicited local symptoms
Timeframe: During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix-B vaccine
Number of subjects reporting solicited general symptoms
Timeframe: During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix-B vaccine
Number of subjects reporting unsolicited adverse events (AEs)
Timeframe: During the 31-day (Days 0-30) follow-up period after a challenge dose of Engerix-B vaccine
Number of subjects reporting serious adverse events (SAEs)
Timeframe: After the challenge dose of Engerix-B vaccine up to the study end
Interventions:
Biological/vaccine: Engerix™-B
Enrollment:
185
Observational study model:
Not applicable
Primary completion date:
2010-26-11
Time perspective:
Not applicable
Clinical publications:
Avdicova M et al. (2015) Lasting immune memory against hepatitis B following challenge 10-11 years after primary vaccination with either three doses of hexavalent DTPa-HBV-IPV/Hib or monovalent hepatitis B vaccine at 3, 5 and 11-12 months of age. Vaccine. 33(23):2727-2733. doi: 10.1016/j.vaccine.2014.06.070. Epub 2014 Jun 22.
Medical condition
Hepatitis B
Product
SB217744, SKF103860
Collaborators
Not applicable
Study date(s)
June 2010 to November 2010
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
11 - 12 years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that their parents/Legally acceptable representative) can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female aged 11-12 years at the time of study entry (from and including the 11th birthday until and excluding the 13th birthday).
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Child in care.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female aged 11-12 years at the time of study entry (from and including the 11th birthday until and excluding the 13th birthday).
- Written informed consent obtained from the parent or Legally Acceptable Representative of the subject.
- Study procedures will be explained to subjects and depending on their understanding, optional informed assent will be sought at the discretion of the investigator.
- Written informed assent obtained from the subject in addition to the informed consent signed by the parent(s)/ Legally Acceptable Representative (s).
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects who have received all three doses of Infanrix hexa or Engerix-B in the primary study 217744/031 (NCT01457495).
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Subjects who the investigator believes that their parents/Legally acceptable representative) can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion criteria:
- Child in care.
- Use of any investigational or non-registered product drug or vaccine) other than the study vaccine within 30 days preceding the challenge dose of HBV vaccine, or planned use during the study period.
- Receipt of hepatitis B (containing) vaccine after vaccination in the primary study 217744/031 (NCT01457495).
- History of hepatitis B disease.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after the HBV vaccine challenge dose.
- Administration of immunoglobulins and/or any blood products within the three months preceding the challenge dose of HBV vaccine or planned administration during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose of HBV vaccine.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- Known hypersensitivity to any component of the HBV vaccine or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component.
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic setting
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-26-11
Actual study completion date
2010-26-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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